FDA DevicesClass II
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY...
Published: May 20, 2026Recall ID: Z-2175-2026Category: devicesCountry: US
Reason for Recall / Hazard
Incomplete seals on sterile product
Product Description & Identification
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Additional Source Details
| Field | Value |
|---|---|
| City | Tempe |
| State | AZ |
| Event id | 98708 |
| Address 1 | 1810 W Drake Dr |
| Code info | UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686. |
| Postal code | 85283-4327 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 61 units |
| Reason for recall | Incomplete seals on sterile product |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260410 |
| Center classification date | 20260513 |
Overview
- Recalling FirmStryker Sustainability Solutions
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide and the countries of Israel and Canada.